Leflunomide ratiopharm

Основна информация

  • Търговско наименование:
  • Leflunomide ratiopharm
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Leflunomide ratiopharm
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Immunosuppressants,
  • Терапевтична област:
  • Arthritis, Rheumatoid
  • Терапевтични показания:
  • Leflunomide is indicated for the treatment of adult patients with: active rheumatoid arthritis as a 'disease-modifying antirheumatic drug' (DMARD);, active psoriatic arthritis., Recent or concurrent treatment with hepatotoxic or haematotoxic DMARDs (e.g. methotrexate) may result in an increased risk of serious adverse reactions; therefore, the initiation of leflunomide treatment has to be carefully considered regarding these benefit / risk aspects. Moreover, switching from leflunomide to another DMARD without following the washout procedure may also increase the risk of serious adverse reactions even for a long time after the switching.,
  • Каталог на резюме:
  • Revision: 13

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/002035
  • Дата Оторизация:
  • 28-11-2010
  • EMEA код:
  • EMEA/H/C/002035
  • Последна актуализация:
  • 20-12-2018

Доклад обществена оценка

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© European Medicines Agency, 2015. Reproduction is authorised provided the source is acknowledged.

EMA/438073/2015

EMEA/H/C/002035

EPAR summary for the public

Leflunomide ratiopharm

leflunomide

This is a summary of the European public assessment report (EPAR) for Leflunomide ratiopharm. It

explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to

reach its opinion in favour of granting a marketing authorisation and its recommendations on the

conditions of use for Leflunomide ratiopharm.

What is Leflunomide ratiopharm?

Leflunomide ratiopharm is a medicine that contains the active substance leflunomide. It is available as

white round tablets (10 and 20 mg).

Leflunomide ratiopharm is a ‘generic medicine’. This means that Leflunomide ratiopharm is similar to a

‘reference medicine’ already authorised in the European Union (EU) called Arava. For more information

on generic medicines, see the question-and-answer document here

What is Leflunomide ratiopharm used for?

Leflunomide ratiopharm is used to treat adults with active rheumatoid arthritis (an immune system

disease causing inflammation of the joints) or active psoriatic arthritis (a disease causing red, scaly

patches on the skin and inflammation of the joints).

The medicine can only be obtained with a prescription.

How is Leflunomide ratiopharm used?

Leflunomide ratiopharm treatment should be started and supervised by a specialist who has experience

in the treatment of rheumatoid arthritis and psoriatic arthritis. The doctor should carry out blood tests

to check the patient’s liver, white blood cell counts and platelet counts before prescribing Leflunomide

ratiopharm, and regularly during treatment.

Leflunomide ratiopharm

EMA/438073/2015

Page 2/2

Leflunomide ratiopharm treatment starts with a ‘loading dose’ of 100 mg once a day for three days,

followed by a maintenance dose. The recommended maintenance dose is 10 to 20 mg once a day in

patients with rheumatoid arthritis, and 20 mg once a day in patients with psoriatic arthritis. The

medicine usually starts to have an effect after four to six weeks. Its effect may improve further for up

to six months.

How does Leflunomide ratiopharm work?

The active substance in Leflunomide ratiopharm, leflunomide, is an immunosuppressant. It reduces

inflammation by reducing the production of immune cells called ‘lymphocytes’, which are responsible

for inflammation. Leflunomide does this by blocking an enzyme called ‘dihydroorotate dehydrogenase’,

which is necessary for the lymphocytes to multiply. With fewer lymphocytes, there is less

inflammation, helping to control the symptoms of arthritis.

How has Leflunomide ratiopharm been studied?

The applicant presented data on experimental models from the scientific literature.

Because Leflunomide ratiopharm is a generic medicine, studies in patients have been limited to tests to

determine that it is bioequivalent to the reference medicine, Arava. Two medicines are bioequivalent

when they produce the same levels of the active substance in the body.

What are the benefits and risks of Leflunomide ratiopharm?

Because Leflunomide ratiopharm is a generic medicine and is bioequivalent to the reference medicine,

its benefit and risk are taken as being the same as the reference medicine’s.

Why has Leflunomide ratiopharm been approved?

The CHMP concluded that, in accordance with EU requirements, Leflunomide ratiopharm has been

shown to have comparable quality and to be bioequivalent to Arava. Therefore, the CHMP’s view was

that, as for Arava, the benefit outweighs the identified risk. The Committee recommended that

Leflunomide ratiopharm be given marketing authorisation.

Other information about Leflunomide ratiopharm

The European Commission granted a marketing authorisation valid throughout the European Union for

Leflunomide ratiopharm on 29 November 2010.

The full EPAR for Leflunomide ratiopharm can be searched for on the Agency’s website

ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports

. For more

information about treatment with Leflunomide ratiopharm, read the package leaflet (also part of the

EPAR) or contact your doctor or pharmacist.

This summary was last updated in 04-2015.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

Package leaflet: Information for the user

Leflunomide ratiopharm 10 mg film-coated tablets

Leflunomide

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See section 4.

What is in this leaflet

What Leflunomide ratiopharm is and what it is used for

What you need to know before you take Leflunomide ratiopharm

How to take Leflunomide ratiopharm

Possible side effects

How to store Leflunomide ratiopharm

Contents of the pack and other information

1.

What Leflunomide ratiopharm is and what it is used for

Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of

medicines called anti-rheumatic medicines.

Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active

psoriatic arthritis.

Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and

pain. Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and

anemia (lack of red blood cells).

Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain

and patches of red, scaly skin (skin lesions).

2.

What you need to know before you take Leflunomide ratiopharm

Do not take Leflunomide ratiopharm

if you have ever had an

allergic

reaction to leflunomide (especially a serious skin reaction,

often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson

syndrome), to peanut or soya or to any of the other ingredients of this medicine (listed in section

if you have any

liver problems

if you have moderate to severe

kidney problems

if you have severely low numbers of

proteins in your blood

(hypoproteinaemia),

if you suffer from any problem which affects your

immune system

(e.g. AIDS),

if you have any problem with your

bone marrow,

or if you have low numbers of red or white

cells in your blood or a reduced number of blood platelets,

if you are suffering from a

serious infection

if you are

pregnant

, think you may be pregnant,

or are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Leflunomide ratiopharm

if you have ever suffered from

interstitial lung disease.

if you have ever had

tuberculosis

or if you have been in close contact with someone who has or

has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.

if you are due to have

a specific blood test (calcium level).

Falsely low levels of calcium can

be detected.

if you are

male

and wish to father a child. As it can not be excluded that Leflunomide

ratiopharm passes into semen, reliable contraception should be used during treatment with

Leflunomide ratiopharm. Men wishing to father a child should contact their doctor who may

advise them to stop taking Leflunomide ratiopharm and take certain medicines to remove

Leflunomide ratiopharm rapidly and sufficiently from their body. You will then need a blood

test to make sure that Leflunomide ratiopharm has been sufficiently removed from your body,

and you should then wait for at least another 3 months before attempting to father a child.

Leflunomide ratiopharm can occasionally cause some problems with your blood, liver, lungs or nerves

in your arms or legs. It may also cause some serious allergic reactions (including Drug Reaction with

Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection. For

more information on these, please read section 4 (Possible side effects).

DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high

temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white

blood cell (eosinophilia) and enlarged lymph nodes.

Your doctor will carry out

blood tests

at regular intervals, before and during treatment with

Leflunomide ratiopharm, to monitor your blood cells and liver. Your doctor will also check your blood

pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.

Tell your doctor if you have unexplained chronic diarrhoea. Your doctor may perform additional tests

for differential diagnosis.

Children and adolescents

Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years

of age.

Other medicines and Leflunomide ratiopharm

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes medicines obtained without a prescription.

This is especially important if you are taking:

other medicines for

rheumatoid arthritis

such as antimalarials (e.g. chloroquine and

hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other

immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable,

warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce

the risk of side effects of this medicine

teriflunomide for multiple sclerosis

repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes

daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer

duloxetine for depression, urinary incontinence or in kidney disease in diabetics

alosetron for the management of severe diarrhoea

theophylline for asthma

tizanidine, a muscle relaxant

oral contraceptives (containing ethinylestradiol and levonorgestrel)

cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections

indomethacin, ketoprofen for pain or inflammation

furosemide for heart disease (diuretic, water pill)

zidovudine for HIV infection

rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)

sulfasalazine for inflammatory bowel disease or rheumatoid arthritis

a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal

these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the

body.

If you are already taking a nonsteroidal

anti-inflammatory

drug (NSAID) and/or

corticosteroids

you may continue to take them after starting Leflunomide ratiopharm.

Vaccinations

If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given

while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment.

Leflunomide ratiopharm with food, drink and alcohol

Leflunomide ratiopharm may be taken with or without food.

It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm. Drinking

alcohol while taking Leflunomide ratiopharm may increase the chance of liver damage.

Pregnancy and breast-feeding

Do not

take Leflunomide ratiopharm if you are, or think you may be

pregnant

. If you are pregnant or

become pregnant while taking Leflunomide ratiopharm, the risk of having a baby with serious birth

defects is increased. Women of childbearing potential must not take Leflunomide ratiopharm without

using reliable contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide

ratiopharm, as you need to ensure that all traces of Leflunomide ratiopharm have left your body before

trying to become pregnant. This may take up to 2 years. This may be reduced to a few weeks by taking

certain medicines which speed up removal of Leflunomide ratiopharm from your body.

In either case it should be confirmed by a blood test that Leflunomide ratiopharm has been sufficiently

removed from your body and you should then wait for at least another month before you become

pregnant.

For further information on the laboratory testing please contact your doctor.

If you suspect that you are pregnant while taking Leflunomide ratiopharm or in the two years after you

have stopped treatment, you must contact your doctor

immediately

for a pregnancy test. If the test

confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove

Leflunomide ratiopharm rapidly and sufficiently from your body, as this may decrease the risk to your

baby.

Do not

take Leflunomide ratiopharm when you are

breast-feeding

, as leflunomide passes into the

breast milk.

Driving and using machines

Leflunomide ratiopharm can make you feel dizzy which may impair your ability to concentrate and

react. If you are affected, do not drive, or use machines.

Leflunomide ratiopharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.

Leflunomide ratiopharm contains soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

3.

How to take Leflunomide ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The usual starting dosage of Leflunomide ratiopharm is 100 mg once daily for the first three days.

After this, most patients need a dose of:

For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the

severity of the disease.

For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.

Swallow

the tablet

whole

and with plenty of

water

It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some

patients may even still feel further improvements after 4 to 6 months of therapy.

You will normally take Leflunomide ratiopharm over long periods of time.

If you take more Leflunomide ratiopharm than you should

If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical

advice. If possible, take your tablets or the box with you to show the doctor.

If you forget to take Leflunomide ratiopharm

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next

dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor

immediately

and stop taking Leflunomide ratiopharm:

if you experience

weakness

, feel light-headed or dizzy or have

difficulty breathing,

as these

may be signs of a serious allergic reaction,

if you develop a

skin rash

ulcers in your mouth

, as these may indicate severe, sometimes

life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema

multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.

Tell your doctor

immediately

if you experience:

pale skin

tiredness,

bruising,

as these may indicate blood disorders caused by an imbalance

in the different types of blood cells which make up blood,

tiredness

abdominal pain

, or

jaundice

(yellow discolouration of the eyes or skin), as these

may indicate serious conditions such as liver failure, which may be fatal,

any symptoms of an

infection

such as

fever, sore throat

cough,

as this medicine may

increase the chance of a severe infection which may be life-threatening,

cough

breathing problems

as these may indicate problems of the lung (interstitial lung

disease or pulmonary hypertension),

unusual tingling, weakness or pain in your hands or feet as these may indicate problems with

your nerves (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

a slight decrease in the number of white blood cells (leucopenia),

mild allergic reactions,

loss of appetite, weight loss (usually insignificant),

tiredness (asthenia),

headache, dizziness,

abnormal skin sensations like tingling (paraesthesia),

mild increase in blood pressure,

diarrhoea,

colitis,

nausea, vomiting,

inflammation of the mouth or mouth ulcers,

abdominal pain,

an increase in some liver test results,

increased hair loss,

eczema, dry skin, rash, itching,

tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the

feet or hands),

an increase of certain enzymes in the blood (creatine phosphokinase),

problems in the nerves of the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood

platelets (thrombocytopenia),

a decrease in the levels of potassium in the blood,

anxiety,

taste disturbances,

urticaria (nettle rash),

tendon rupture,

an increase in the levels of fat in the blood (cholesterol and triglycerides),

a decrease in the levels of phosphate in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the

number of white blood cells (leucopenia); decrease in the number of all blood cells

(pancytopenia),

severe increase in blood pressure,

inflammation of the lung (interstitial lung disease),

an increase in some liver results which may develop into serious conditions such as hepatitis

and jaundice,

severe infections called sepsis which may be fatal,

an increase of certain enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

a marked decrease of some white blood cells (agranulocytosis),

severe and potentially severe allergic reactions,

inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),

inflammation of the pancreas (pancreatitis),

severe liver injury such as liver failure or necrosis which may be fatal,

severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal

necrolysis, erythema multiforme).

Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary

hypertension, male infertility (which is reversible once treatment with this medicine is stopped),

cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis

(new or worsening) and DRESS may also occur with a not known frequency.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Leflunomide ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after

EXP. The expiry date refers to the last day of that month.

Keep the bottle tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Leflunomide ratiopharm contains

The active substance is leflunomide.

One film-coated tablet contains 10 mg of leflunomide.

The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric

acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans),

poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating

What Leflunomide ratiopharm looks like and contents of the pack

Leflunomide ratiopharm 10 mg film-coated tablets are white to almost white and round with a

diameter of about 6 mm.

The tablets are packed in bottles.

Pack sizes of 30 and 100 film-coated tablets per bottle are available.

Not all pack size may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB "Sicor Biotech"

Tel: +370 5 266 0203

България

Тева Фармасютикълс България ЕООД

Teл: +359 2 489 95 82

Luxembourg/Luxemburg

ratiopharm GmbH, Allemagne/Deutschland

Tél/Tel: +35 731 402 02

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 64 00

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland, L-Irlanda

Tel: +353 51 321 740

Deutschland

ratiopharm GmbH

Tel: +49 731 402 02

Nederland

Teva Nederland B.V.

Tel: +31 (0)800 0228 400

Eesti

Teva Eesti esindus

UAB "Sicor Biotech" Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97 007 0

España

ratiopharm España, S.A.

Tel: +34 91 567 29 70

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

France

Teva Santé

Tél: +33 1 55 91 78 00

Portugal

ratiopharm, Comércio e Indústria de Produtos

Farmacêuticos Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +40 21 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 (0)51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy, Finland

Sími: +358 20 180 5900

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57 26 79 11

Italia

Teva Italia S.r.l.

Tel: +39 02 891 798 1

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 (0)42 12 11 00

Latvija

UAB "Sicor Biotech" filiāle Latvijā

Tel: +371 673 236 66

United Kingdom

Teva UK Limited

Tel: +44 (0)1977 628500

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu/

Package leaflet: Information for the user

Leflunomide ratiopharm 20 mg film-coated tablets

Leflunomide

Read all of this leaflet carefully before you start taking this medicine because it contains

important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor,pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

If you get any side effects , talk to your doctor, pharmacist or nurse. This includes any possible

side effects not listed in this leaflet. See sextion 4.

What is in this leaflet

What Leflunomide ratiopharm is and what it is used for

What you need to know before you take Leflunomide ratiopharm

How to take Leflunomide ratiopharm

Possible side effects

How to store Leflunomide ratiopharm

Contents of the pack and other information

1.

What Leflunomide ratiopharm is and what it is used for

Leflunomide ratiopharm contains the active substance leflunomide which belongs to a group of

medicines called anti-rheumatic medicines.

Leflunomide ratiopharm is used to treat adult patients with active rheumatoid arthritis or with active

psoriatic arthritis.

Symptoms of rheumatoid arthritis include inflammation of joints, swelling, difficulty moving and

pain. Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and

anemia (lack of red blood cells).

Symptoms of active psoriatic arthritis include inflammation of joints, swelling, difficulty moving, pain

and patches of red, scaly skin (skin lesions).

2.

What you need to know before you take Leflunomide ratiopharm

Do not take Leflunomide ratiopharm

if you have ever had an

allergic

reaction to leflunomide (especially a serious skin reaction,

often accompanied by fever, joint pain, red skin stains, or blisters e.g. Stevens-Johnson

syndrome), to peanut or soya or to any of the other ingredients of this medicine (listed in section

if you have any

liver problems

if you have moderate to severe

kidney problems

if you have severely low numbers of

proteins in your blood

(hypoproteinaemia),

if you suffer from any problem which affects your

immune system

(e.g. AIDS),

if you have any problem with your

bone marrow,

or if you have low numbers of red or white

cells in your blood or a reduced number of blood platelets,

if you are suffering from a

serious infection

if you are

pregnant

, think you may be pregnant,

or are breast-feeding.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Leflunomide ratiopharm

if you have ever suffered from

interstitial lung desease.

if you have ever had

tuberculosis

or if you have been in close contact with someone who has or

has had tuberculosis. Your doctor may perform tests to see if you have tuberculosis.

if you are due to have

a specific blood test (calcium level).

Falsely low levels of calcium can

be detected.

if you are

male

and wish to father a child. As it can not be excluded that Leflunomide

ratiopharm passes into semen, reliable contraception should be used during treatment with

Leflunomide ratiopharm. Men wishing to father a child should contact their doctor who may

advise them to stop taking Leflunomide ratiopharm and take certain medicines to remove

Leflunomide ratiopharm rapidly and sufficiently from their body. You will then need a blood

test to make sure that Leflunomide ratiopharm has been sufficiently removed from your body,

and you should then wait for at least another 3 months before attempting to father a child.

Leflunomide ratiopharm can occasionally cause some problems with your blood, liver, lungs or nerves

in your arms or legs. It may also cause some serious allergic reactions (including Drug Reaction with

Eosinophilia and Systemic Symptoms [DRESS]), or increase the chance of a severe infection. For

more information on these, please read section 4 (Possible side effects).

DRESS appears initially as flu-like symptoms and a rash on the face then an extended rash with a high

temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white

blood cell (eosinophilia) and enlarged lymph nodes.

Your doctor will carry out

blood tests

at regular intervals, before and during treatment with

Leflunomide ratiopharm, to monitor your blood cells and liver. Your doctor will also check your blood

pressure regularly as Leflunomide ratiopharm can cause an increase in blood pressure.

Tell your doctor if you have unexplained chronic diarrhoea. Your doctor may perform additional tests

for differential diagnosis.

Children and adolescents

Leflunomide ratiopharm is not recommended for use in children and adolescents below 18 years

of age.

Other medicines and Leflunomide ratiopharm

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other

medicines. This includes medicines obtained without a prescription.

This is especially important if you are taking:

other medicines for

rheumatoid arthritis

such as antimalarials (e.g. chloroquine and

hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other

immunosuppressive medicines (e.g. methotrexate) as these combinations are not advisable,

warfarin and other oral medicines used to thin the blood, as monitoring is necessary to reduce

the risk of side effects of this medicine

teriflunomide for multiple sclerosis

repaglinide, pioglitazone, nateglinide, or rosiglitazone for diabetes

daunorubicin, doxorubicin, paclitaxel, or topotecan for cancer

duloxetine for depression, urinary incontinence or in kidney disease in diabetics

alosetron for the management of severe diarrhoea

theophylline for asthma

tizanidine, a muscle relaxant

oral contraceptives (containing ethinylestradiol and levonorgestrel)

cefaclor, benzylpenicillin (penicillin G), ciprofloxacin for infections

indomethacin, ketoprofen for pain or inflammation

furosemide for heart disease (diuretic, water pill)

zidovudine for HIV infection

rosuvastatin, simvastatin, atorvastatin, pravastatin for hypercholesterolemia (high cholesterol)

sulfasalazine for inflammatory bowel disease or rheumatoid arthritis

a medicine called colestyramine (used to reduce high cholesterol) or activated charcoal

these medicines can reduce the amount of Leflunomide ratiopharm which is absorbed by the

body.

If you are already taking a non-steroidal

anti-inflammatory

drug (NSAID) and/or

corticosteroids

you may continue to take them after starting Leflunomide ratiopharm.

Vaccinations

If you have to be vaccinated, ask your doctor for advice. Certain vaccinations should not be given

while taking Leflunomide ratiopharm, and for a certain amount of time after stopping treatment.

Leflunomide ratiopharm with food, drink and alcohol

Leflunomide ratiopharm may be taken with or without food.

It is not recommended to drink alcohol during treatment with Leflunomide ratiopharm. Drinking

alcohol while taking Leflunomide ratiopharm may increase the chance of liver damage.

Pregnancy and breast-feeding

Do not

take Leflunomide ratiopharm if you are, or think you may be

pregnant

. If you are pregnant or

become pregnant while taking Leflunomide ratiopharm, the risk of having a baby with serious birth

defects is increased. Women of childbearing potential must not take Leflunomide ratiopharm without

using reliable contraceptive measures.

Tell your doctor if you plan to become pregnant after stopping treatment with Leflunomide

ratiopharm, as you need to ensure that all traces of Leflunomide ratiopharm have left your body before

trying to become pregnant. This may take up to 2 years. This may be reduced to a few weeks by taking

certain medicines which speed up removal of Leflunomide ratiopharm from your body.

In either case it should be confirmed by a blood test that Leflunomide ratiopharm has been sufficiently

removed from your body and you should then wait for at least another month before you become

pregnant.

For further information on the laboratory testing please contact your doctor.

If you suspect that you are pregnant while taking Leflunomide ratiopharm or in the two years after you

have stopped treatment, you must contact your doctor

immediately

for a pregnancy test. If the test

confirms that you are pregnant, your doctor may suggest treatment with certain medicines to remove

Leflunomide ratiopharm rapidly and sufficiently from your body, as this may decrease the risk to your

baby.

Do not

take Leflunomide ratiopharm when you are

breast-feeding

, as leflunomide passes into the

breast milk.

Driving and using machines

Leflunomide ratiopharm can make you feel dizzy which may impair your ability to concentrate and

react. If you are affected, do not drive, or use machines.

Leflunomide ratiopharm contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor

before taking this medicine.

Leflunomide ratiopharm contains soya lecithin

If you are allergic to peanut or soya, do not use this medicine.

3.

How to take Leflunomide ratiopharm

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor

or pharmacist if you are not sure.

The usual starting dosage of Leflunomide ratiopharm is 100 mg once daily for the first three days.

After this, most patients need a dose of:

For rheumatoid arthritis: 10 or 20 mg Leflunomide ratiopharm once daily, depending on the

severity of the disease.

For psoriatic arthritis: 20 mg Leflunomide ratiopharm once daily.

Take the tablet with plenty of water.

It may take about 4 weeks or longer until you start to feel an improvement in your condition. Some

patients may even still feel further improvements after 4 to 6 months of therapy.

You will normally take Leflunomide ratiopharm over long periods of time.

If you take more Leflunomide ratiopharm than you should

If you take more Leflunomide ratiopharm than you should, contact your doctor or get other medical

advice. If possible, take your tablets or the box with you to show the doctor.

If you forget to take Leflunomide ratiopharm

If you forget to take a dose, take it as soon as you remember, unless it is nearly time for your next

dose. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor

immediately

and stop taking Leflunomide ratiopharm:

if you experience

weakness

, feel light-headed or dizzy or have

difficulty breathing,

as these

may be signs of a serious allergic reaction,

if you develop a

skin rash

ulcers in your mouth

, as these may indicate severe, sometimes

life-threatening reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema

multiforme, Drug Reaction with Eosinophilia and Systemic Symptoms [DRESS]), see section 2.

Tell your doctor

immediately

if you experience:

pale skin

tiredness,

bruising,

as these may indicate blood disorders caused by an imbalance

in the different types of blood cells which make up blood,

tiredness

abdominal pain

, or

jaundice

(yellow discolouration of the eyes or skin), as these

may indicate serious conditions such as liver failure, which may be fatal,

any symptoms of an

infection

such as

fever, sore throat

cough,

as this medicine may

increase the chance of a severe infection which may be life-threatening,

cough

breathing problems

as these may indicate problems of the lung (interstitial lung

disease or pulmonary hypertension),

unusual tingling, weakness or pain in your hands or feet as these may indicate problems with

your nerves (peripheral neuropathy).

Common side effects (may affect up to 1 in 10 people)

a slight decrease in the number of white blood cells (leucopenia),

mild allergic reactions,

loss of appetite, weight loss (usually insignificant),

tiredness (asthenia),

headache, dizziness,

abnormal skin sensations like tingling (paraesthesia),

mild increase in blood pressure,

diarrhoea,

colitis,

nausea, vomiting,

inflammation of the mouth or mouth ulcers,

abdominal pain,

an increase in some liver test results,

increased hair loss,

eczema, dry skin, rash, itching,

tendonitis (pain caused by inflammation in the membrane surrounding the tendons usually in the

feet or hands),

an increase of certain enzymes in the blood (creatine phosphokinase),

problems in the nerves of the arms or legs (peripheral neuropathy).

Uncommon side effects (may affect up to 1 in 100 people)

a decrease in the number of red blood cells (anaemia) and a decrease in the number of blood

platelets (thrombocytopenia),

a decrease in the levels of potassium in the blood,

anxiety,

taste disturbances,

urticaria (nettle rash),

tendon rupture,

an increase in the levels of fat in the blood (cholesterol and triglycerides),

a decrease in the levels of phosphate in the blood.

Rare side effects (may affect up to 1 in 1,000 people)

an increase in the numbers of blood cells called eosinophiles (eosinophilia); mild decrease in the

number of white blood cells (leucopenia); decrease in the number of all blood cells

(pancytopenia),

severe increase in blood pressure,

inflammation of the lung (interstitial lung disease),

an increase in some liver results which may develop into serious conditions such as hepatitis

and jaundice,

severe infections called sepsis which may be fatal,

an increase of certain enzymes in the blood (lactate dehydrogenase).

Very rare side effects (may affect up to 1 in 10,000 people)

a marked decrease of some white blood cells (agranulocytosis),

severe and potentially severe allergic reactions,

inflammation of the small vessels (vasculitis, including cutaneous necrotizing vasculitis),

inflammation of the pancreas (pancreatitis),

severe liver injury such as liver failure or necrosis which may be fatal,

severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal

necrolysis, erythema multiforme).

Other side effects such as kidney failure, a decrease in the levels of uric acid in your blood, pulmonary

hypertension, male infertility (which is reversible once treatment with this medicine is stopped),

cutaneous lupus (characterized by rash/erythema on skin areas that are exposed to light), psoriasis

(new or worsening) and DRESS may also occur with a not known frequency.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Leflunomide ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the outer carton and on the bottle after

EXP. The expiry date refers to the last day of that month.

Keep the bottle tightly closed in order to protect from moisture.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to

throw away medicines you no longer use. These measures will help protect the environment.

6.

Contents of the pack and other information

What Leflunomide ratiopharm contains

The active substance is leflunomide.

One film-coated tablet contains 20 mg of leflunomide.

The other ingredients are lactose monohydrate, low-substituted hydroxypropyl cellulose, tartaric

acid, sodium laurylsulfate and magnesium stearate in the tablet core as well as lecithin (soybeans) ,

poly(vinyl alcohol), talc, titanium dioxide (E171) and xanthan gum in the film-coating

What Leflunomide ratiopharm looks like and contents of the pack

Leflunomide ratiopharm 20 mg film-coated tablets are white to almost white and round with a

diameter of about 8 mm and a break-mark on one side of the tablet. The tablet can be divided into

equal halves.

The tablets are packed in bottles.

Pack sizes of 30 and 100 film-coated tablets per bottle are available.

Not all pack size may be marketed.

Marketing Authorisation Holder

ratiopharm GmbH

Graf-Arco-Straße 3

89079 Ulm

Germany

Manufacturer

Haupt Pharma Münster GmbH

Schleebrüggenkamp 15

48159 Münster

Germany

Merckle GmbH

Ludwig-Merckle-Straße 3

89143 Blaubeuren

Germany

For any information about this medicine, please contact the local representative of the Marketing

Authorisation Holder:

België/Belgique/Belgien

Teva Pharma Belgium N.V./S.A./AG

Tél/Tel: +32 3 820 73 73

Lietuva

UAB "Sicor Biotech"

Tel: +370 5 266 0203

България

Тева Фармасютикълс България ЕООД

Luxembourg/Luxemburg

ratiopharm GmbH, Allemagne/Deutschland

Teл: +359 2 489 95 82

Tél/Tel: +35 731 402 02

Česká republika

Teva Pharmaceuticals CR, s.r.o.

Tel: +420 251 007 111

Magyarország

Teva Gyógyszergyár Zrt.

Tel.: +36 1 288 64 00

Danmark

Teva Denmark A/S

Tlf: +45 44 98 55 11

Malta

Teva Pharmaceuticals Ireland, L-Irlanda

Tel: +353 51 321 740

Deutschland

ratiopharm GmbH

Tel: +49 731 402 02

Nederland

Teva Nederland B.V.

Tel: +31 (0) 800 0228 400

Eesti

Teva Eesti sindus

UAB "Sicor Biotech" Eesti filiaal

Tel: +372 661 0801

Norge

Teva Norway AS

Tlf: +47 66 77 55 90

Ελλάδα

Teva Ελλάς Α.Ε.

Τηλ: +30 210 72 79 099

Österreich

ratiopharm Arzneimittel Vertriebs-GmbH

Tel: +43 1 97 007 0

España

ratiopharm España, S.A.

Tel: +34 91 567 29 70

Polska

Teva Pharmaceuticals Polska Sp. z o.o.

Tel.: +48 22 345 93 00

France

Teva Santé

Tél: +33 1 55 91 78 00

Portugal

ratiopharm, Comércio e Indústria de Produtos

Farmacêuticos Lda

Tel: +351 21 476 75 50

Hrvatska

Pliva Hrvatska d.o.o.

Tel: +385 1 37 20 000

România

Teva Pharmaceuticals S.R.L

Tel: +40 21 230 65 24

Ireland

Teva Pharmaceuticals Ireland

Tel: +353 (0)51 321 740

Slovenija

Pliva Ljubljana d.o.o.

Tel: +386 1 58 90 390

Ísland

ratiopharm Oy, Finland

Sími: +358 20 180 5900

Slovenská republika

Teva Pharmaceuticals Slovakia s.r.o.

Tel: +421 2 57 26 79 11

Italia

Teva Italia S.r.l.

Tel: +39 02 891 798 1

Suomi/Finland

ratiopharm Oy

Puh/Tel: +358 20 180 5900

Κύπρος

Teva Ελλάς Α.Ε., Ελλάδα

Τηλ: +30 210 72 79 099

Sverige

Teva Sweden AB

Tel: +46 (0)42 12 11 00

Latvija

UAB "Sicor Biotech" filiāle Latvijā

Tel: +371 673 236 66

United Kingdom

Teva UK Limited

Tel: +44 (0)1977 628500

This leaflet was last revised in {MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website:

http://www.ema.europa.eu/